First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

Hearing Loss, Sensorineural Clinical Trial

Official title:

A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05664100
• Other study ID #: FX-345-101
• Status: Terminated
• Phase: Phase 1
• Start date: December 15, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2023
• Source: Frequency Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

Description:

This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Adult aged 18-67 years (inclusive)
• Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
• At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected
• Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test.
• Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception

Exclusion Criteria:

• Randomization in a FX-322 (laduviglusib and sodium valproate) clinical trial
• Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
• Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
• Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
• Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
• Evidence of or previous diagnosis of traumatic brain injury, Meniere's disease, or genetic hearing loss
• History of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms
• Exposure to another investigational drug within 28 days prior to screening visit

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• FX-345
Single intratympanic injection of FX-345
• Placebo
Single intratympanic injection of placebo

Locations

Country	Name	City	State
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	Sarasota	Florida
United States	Clinical Trial Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Frequency Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)		Baseline Through Day 90
Primary	Cmax	Maximum (peak) observed plasma drug concentration of FX04 and FX00 in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Primary	AUClast	Area under the concentration-time curve of FX04 and FX00 in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Primary	CL/F	Apparent total body clearance of FX04 and FX00 in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Primary	Vss	Apparent volume of distribution at steady state of FX04 and FX00 in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Primary	t1/2	Elimination half-life of FX04 and FX00 in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Primary	Tmax	Time to reach maximum (peak) plasma drug concentration of FX04 and FX00 in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Primary	Elimination rate constant	The rate at which FX04 and FX00 is removed from the human system in cohort 1 participants	Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose